Date: May 27, 2020
Location: Morrisville, NC, US
Expected Travel: Up to 10%
Requisition ID: 2467
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Anesthesia and Emergency Medicine - At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. Through collaboration with global clinical experts, we lead the way in the development of technology, clinical research and education to improve practice in a meaningful way. Today, our LMA and Rsch brands include some of the most advanced airway management devices on the market. The Arrow portfolio of pain management products is designed to improve patients' post-operative pain experience. And our Arrow EZ-IO System helps address the time-critical challenge of emergency intraosseous vascular access. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
This Morrisville, North Carolina based position provides risk management and design assurance support in the development of new medical device products, sustaining engineering projects and cost improvement initiatives that are attached to the Anesthesia and Emergency Medicine Business Unit. Products supported include regional anesthesia (pain management), airway (endotracheal and tracheostomy tubes as well as supraglottic airways and laryngoscopes), atomization and intraosseous (emergency medicine venous access) product families. This role also facilitates the application of design control to ensure the highest quality of the devices being developed and/or revised.
Lead design assurance activities and provide appropriate engineering/technical assessments supporting the design history file.
Maintain the risk management files - produce risk management documentation (DFMEAs, PFMEAs, hazards analyses, risk management plans and risk management reports) in accordance with internal procedures, applicable quality system, and external regulations and standards.
Develop and maintain risk management policies and procedures.
Author post-production risk assessments, post-launch market reviews, and health hazards evaluations.
Provide guidance to internal customers for design control, development of test methods, test protocols, critical criteria, establishing initial project deliverables, etc.
Participate in design reviews, design transfer process, and support design verification and validation activities.
Improve quality system documentation.
Participation in design testing - setting acceptance criteria, use of standards, analysis of data.
Support manufacturing operations with quality issues.
Represent quality engineering on project teams.
Suggest sound techniques to solve problems and make design/process improvement recommendations through six sigma studies, design of experiments to identify critical variables in any process and establish design limitations and statistical support.
Conduct failure and reliability testing, and root cause analysis as a result of complaints, nonconforming material and product, etc.
Analyze product complaints. Confirm complaint and determines root causes, as requested.
Interface with various internal and external resources such as manufacturing, R&D, marketing, and/or regulatory affairs to assist with obtaining completed information regarding product complaints, as requested.
Champion compliance to applicable standards.
Coordinate puchased finished goods specifications development between various internal customers.
Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
Adhere to and ensure the compliance with Teleflex Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
As requested, provide risk management information for management reviews, QSRB meetings and other business units/departments.
Mentor new quality engineers and other functional team members.
Education / Experience Requirements
A bachelor degree in engineering is required, with a minimum of six years of work experience, ideally in quality engineering, or quality engineering and direct R&D engineering. Ideal engineering degrees would include biomedical or mechanical engineering. A master's degree in Engineering would be a strong plus.
Prior experience in the medical device industry is expected. Possession of Master of Science Degree in Engineering or closely related field; possession of Master of Science Degree may be substituted for six (5) additional years of work experience in the Medical devices. Preferred in the anesthesia fields
ASQ Certified Quality Engineer preferred.
Five years of related experiences with participation in project management and cross functional teams.
Specialized Skills / Other Requirements
Experience with IEC 60601-1 standards preferred.
Reliability Engineering experience preferred
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.